FDA Adverse Event
Injury
Summary report: N
NA
MDR report key: 492089
·
Received October 27, 2003
Report
- Report Number
- 2242056-2003-00006
- Event Type
- Injury
- Date Received
- October 27, 2003
- Date of Event
- October 8, 2003
- Report Date
- October 21, 2003
- Manufacturer
- ALTO DEVELOPMENT CORP., DBA A&E MEDICAL CORP.
- Product Code
- GEI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
BURN TO PT'S LIP NOTED DURING TONSILLECTOMY PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NA | ELECTROSURGICAL SUCTION COAGULATOR | GEI | ALTO DEVELOPMENT CORP., DBA A&E MEDICAL CORP. | NA | 009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |